Regulatory Roundup: Top News Stories – Week Ending May 19, 2017
There have been a lot of regulatory announcements so far this week. Here are the top ten stories for regulatory professionals to follow:
- Scott Gottlieb, the newly sworn-in commissioner of the FDA indicated that he plans to put rising drug prices front and center as he shapes his regulatory agenda http://www.biopharmadive.com/news/gottlieb-fda-drug-prices-generics-lower-cost/442824/
- Ionis Pharmaceuticals met primary endpoints in its Phase III study for an investigational neurological dysfunction drug. Ionis is currently preparing marketing applications for the drug and GSK has an option to license this program prior to submission for regulatory approval. However, there were three serious adverse events and one patient died of intracranial hemorrhage. http://www.genengnews.com/gen-news-highlights/ionis-antisense-drug-meets-primary-endpoints-in-phase-iii-fap-study/81254349?utm
- Loxo Oncology announced that the FDA has granted orphan drug designation to larotrectinib for the treatment of solid tumors with NTRK-fusion proteins. NTRK fusions are genetic abnormalities that occur rarely in various adult and pediatric solid tumors. https://www.firstwordpharma.com/node/1471294
- The FDA granted a Breakthrough Therapy Designation to Ignyta’s entrectinib for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors. https://ignyta.com/investors/press-release-article/1026348/
- Bayer won priority review status from the FDA for their investigational blood cancer program. Full story here
- Based on new data from two large clinical trials, the FDA concluded that Janssen’s type 2 diabetes medicine canagliflozin causes an increased risk of leg and foot amputations. Therefore “Boxed Warning,” will be added to the drug labels Full story here.
- Minerva Neurosciences had a positive EOP2 meeting with the FDA and will be kicking off a Phase 3 trial this year for their schizophrenia program. http://www.biopharmadive.com/news/Minerva-schizophrenia-Phase-3-FDA/442822/
- Amgen has submitted a BLA to the FDA for erenumab to prevent migrainesThis BLA includes data from pivotal studies in patients with episodic and chronic migraine. Full story here
- Concert Pharmaceuticals has been hit with a clinical hold on a Phase IIa study of its drug CTP-543 for alopecia areata. The FDA did not cite a safety concern; however, they intend to review these additional non-clinical data as support for the one-year dosing duration as planned in the Phase 2a trial. Full story here
- Shire’s swelling disorder treatment, lanadelumab, has met its primary endpoint and all secondary endpoints in a phase 3 study. Shire intends to file a BLA with the FDA by the end of this year or early 2018. Full story here
In other news…
Biogen has acquired the Phase III-ready stroke treatment candidate Cirara from Remedy Pharmaceuticals for $120 million . Biogen said it plans to continue the development and commercialization of Cirara and has agreed to share in the cost of development for the treatment candidate’s target indication of LHI stroke. http://www.genengnews.com/gen-news-highlights/biogen-acquires-stroke-candidate-cirara-from-remedy-for-120m-upfront/81254352?utm
G1 Therapeutics raised $105 million in an IPO to fund their development programs http://www.xconomy.com/raleigh-durham/2017/05/17/riding-recent-biotech-ipo-wave-g1-snags-105m-to-fund-cancer-work/?utm
Genoa Pharmaceuticals, a biopharmaceutical company focused on development of improved therapies for idiopathic pulmonary fibrosis (IPF) and other severe pulmonary indications, today announced the completion of a $62 million Series A financing. These funds will be used to take their lead candidate into the clinic. http://www.fiercebiotech.com/biotech/genoa-scores-62m-series-a-to-take-ipf-drug-into-clinic?ut
The FDA is looking at modernizing the regulation of combination products. Currently one-third of all medical products under development are combination products (a combination of a drug, device or biologic) http://raps.org/Regulatory-Focus/News/2017/05/15/27548/FDA-Officials-Discuss-Modernizing-the-Regulation-of-Combo-Products/?
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